SMQI15EDANBlood Gas and Chemistry Analyzer

I About this Manual P/N: 01.54.455691-11 Release Date: July, 2013 © Copyright EDAN INSTRUMENTS, INC. 2013. All rights reserved Statement This manual will help you to better understand the operation and maintenance of the product. It is reminded that the product should be used strictly in compliance with this manual. User operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information contained in this manual, shall not be disclosed to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual. Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant environment complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technicians maintain and repair some parts, which EDAN may configure as user serviceable. II Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure. III Table of Contents Chapter 1 Safety Guide ................................................................................................................ 1 1.1 Intended Use....................................................................................................................... 1 1.2 Warnings and Cautions ....................................................................................................... 1 1.2.1 Safety Warnings ..................................................................................................... 1 1.2.2 Safety Cautions ...................................................................................................... 5 1.3 Symbols and Definitions .................................................................................................... 6 Chapter 2 System Overview ......................................................................................................... 8 2.1 Introduction ........................................................................................................................ 8 2.2 System Frame ................................................................................................................... 10 2.3 Analyzer Appearance ....................................................................................................... 12 2.4 System Parts ..................................................................................................................... 13 2.4.1 Thermal Printer .................................................................................................... 13 2.4.2 Test Cartridge ....................................................................................................... 13 2.4.3 Power Indicator .................................................................................................... 15 2.4.4 LCD Screen and Touch Screen ............................................................................ 15 2.4.5 I/O Ports ............................................................................................................... 16 2.4.6 On/Off Button ...................................................................................................... 16 2.4.7 Calibrant Fluid Pack ............................................................................................. 16 2.4.8 Bar Code Scanner ................................................................................................. 17 2.4.9 Exhaust Fan .......................................................................................................... 18 2.4.10 Electronic Simulator........................................................................................... 18 2.4.11 Peripherics .......................................................................................................... 19 2.5 Configuration ................................................................................................................... 20 2.5.1 Standard Configuration ........................................................................................ 20 2.5.2 Options ................................................................................................................. 20 Chapter 3 Installation Guide ...................................................................................................... 21 3.1 Unpacking Inspection....................................................................................................... 21 3.2 Installation Requirements................................................................................................. 21 3.2.1 Environmental Requirements ............................................................................... 21 …

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Edan Instruments, Inc. FCC ID: SMQI15EDAN DATE: Sep 20, 2013 We , Edan Instruments, Inc. doesn’t provide any controls or software to allow the operation outside of the USA frequency band when we sell this product in USA.

Label: FCC ID : SMQI15EDAN This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Label Loaction:

FCC PART 15 SUBPART C TEST REPORT FCC PART 15.247 Report Reference No. ..................... : FCC ID. .............................................: TRE1303011001 R/C: 15431 SMQI15EDAN Compiled by ( position+printed name+signature) .. : File administrators Jerome Luo Supervised by ( position+printed name+signature) .. : Test Engineer Yuchao Wang Approved by ( position+printed name+signature) .. : Manager Wenliang Li Date of issue ..................................... : Sep 25, 2013 Testing Laboratory Name .............. : Shenzhen Huatongwei International Inspection Co., Ltd Address ............................................ : Keji Nan No.12 Road, Hi-tech Park, Shenzhen, China Applicant’s name ............................ : Edan Instruments, Inc. Address ............................................ : 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China Test specification: Standard ........................................... : FCC Part 15.247: Operation within the bands 902-928 MHz, 2400-2483.5 MHz and 5725-5850 MHz TRF Originator .................................. : Shenzhen Huatongwei International Inspection CO., Ltd Master TRF ....................................... : Dated 2006-06 Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection Co., Ltd takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. Test item description ..................... : Blood Gas and Chemistry Analyzer Trade Mark ....................................... : Model/Type reference ....................... : i15 Listed Models .................................. : / Manufacturer .................................. : Edan Instruments, Inc. Modulation Type ............................... : CCK,OFDM Operation Frequency ........................ : From 2412MHz to 2462MHz Rating ............................................... : DC 19V Adapter from AC 120V/60Hz Result................................................ : Positive Report No.: TRE1303011001 Page 2 of 77 Issued:2013-09-25 T E S T R E P O R T Test Report No. : TRE1303011001 Sep 25, 2013 ______________________________________________________________________________________________ Date of issue Equipment under Test : Blood Gas and Chemistry Analyzer Model /Type : i15 Listed Models : / Applicant : Edan Instruments, Inc. Address : 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China Manufacturer Edan Instruments, Inc. Address : 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China Test Result according to the standards on page 4: Positive The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test result without the written permission of the test laboratory. Report No.: TRE1303011001 Page 3 of 77 Issued:2013-09-25 Contents 1. TEST STANDARDS .................................................................. 4 2. SUMMARY ............................................................................. 5 2.1. General Remarks 5 2.2. Equipment Under Test 5 2.3. Description of the test mode 5 2.4. Short description of the Equipment under Test (EUT) 5 2.5. EUT operation mode 5 2.6. EUT configuration 5 2.7. Related Submittal(s) / Grant (s) 6 2.8. Modifications 6 2.9. NOTE 6 3. TEST ENVIRONMENT ............................................................... 7 3.1. Address of the test laboratory 7 3.2. Test Facility 7 3.3. Environmental conditions 8 3.4. Configuration of Tested System 8 3.5. Test Description 8 3.6. Statement of the measurement uncertainty 8 3.7. Equipments Used during the Test 9 4. TEST CONDITIONS AND RESULTS ............................................ 10 4.1. AC Power Conducted Emission 10 4.2. Radiated Emission 13 4.3. Maximum Peak Output Power 22 4.4. Power Spectral Density 29 4.5. Band Edge Compliance of RF Emission 36 4.6. Spurious RF Conducted Emission 45 4.7. 6dB Bandwidth 55 4.8. Antenna Requirement 62 5. TEST SETUP PHOTOS OF THE EUT .......................................... 63 6. EXTERNAL AND INTERNAL PHOTOS OF THE EUT ....................... 65 Report No.: TRE1303011001 Page 4 of 77 Issued:2013-09-25 1. TEST STANDARDS The tests were performed according to following standards: FCC Rules Part 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation within the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz. ANSI C63.10:2009 : American National Standard for Testing Unlicensed Wireless Devices KDB558074 D01 V03: Guidance for Performing Compliance Measurements on Digital Transmission Systems (DTS) Operating Under §15.247 Report No.: TRE1303011001 Page 5 of 77 Issued:2013-09-25 2. SUMMARY 2.1. General Remarks Date of receipt of test sample : Aug 25, 2013 Testing commenced on : Aug 05, 2013 Testing concluded on : Sep 23, 2013 2.2. Equipment Under Test Power supply system utilised Power supply voltage : ○ 120V / 60 Hz ○ 115V / 60Hz ○ 12 V DC ○ 24 V DC ● Other (specified in blank below) DC 19V Adapter from AC 120V/60Hz 2.3. Description of the test mode IEEE 802.11b/g/n: Eleven channels are provided to the EUT. Channel Frequency(MHz) Channel Frequency(MHz) 1 2412 8 2447 2 2417 9 2452 3 2422 10 2457 4 2427 11 2462 5 2432 12 2467 6 2437 13 2472 7 2442 2.4. Short description of the Equipment under Test (EUT) The EUT (Blood Gas and Chemistry Analyzer (M/N:i15)) equiped with a 2.4G wifi module which can transmit data to upper computer for analysis of the necessary. For more details, refer to the user’s manual of the EUT. Serial number: Prototype 2…

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MPE TEST REPORT FCC Per 47 CFR 2.1091(b) Report Reference No. ..................... : FCC ID. ............................................ : TRE1303011002 R/C:15431 SMQI15EDAN Compiled by ( position+printed name+signature) .. : File administrators Jerome Luo Supervised by ( position+printed name+signature) .. : Test Engineer Yuchao Wang Approved by ( position+printed name+signature) .. : Manager Wenliang Li Date of issue ..................................... : Sep 23, 2013 Testing Laboratory Name .............. : Shenzhen Huatongwei International Inspection Co., Ltd Address ............................................. : Keji Nan No.12 Road, Hi-tech Park, Shenzhen, China Applicant’s name ............................ : Edan Instruments, Inc. Address ............................................. : 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China Test specification: Standard ........................................... : FCC Per 47 CFR 2.1091(b) KDB447498 v05r01 TRF Originator .................................. : Shenzhen Huatongwei International Inspection CO., Ltd Master TRF ....................................... : Dated 2006-06 Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection Co., Ltd takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. Test item description .................... : Blood Gas and Chemistry Analyzer Trade Mark ....................................... : Manufacturer .................................... : Edan Instruments, Inc. Model/Type reference ....................... : i15 Listed Models .................................. : / Ratings .............................................. : AC 120V/60Hz Modulation ....................................... : CCK,OFDM Operation Frequency ........................ : From 2412MHz to 2462MHz Result ................................................ : Positive Report No.: TRE1303011002 Page 2 of 7 Issued:2013-09-23 MPE T E S T R E P O R T Test Report No. : TRE1303011002 Sep 23, 2013 ______________________________________________________________________________________________ Date of issue Equipment under Test : Blood Gas and Chemistry Analyzer Model /Type : i15 Listed Models : / Applicant : Edan Instruments, Inc. Address : 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China Manufacturer Edan Instruments, Inc. Address : 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test result without the written permission of the test laboratory. Report No.: TRE1303011002 Page 3 of 7 Issued:2013-09-23 Contents 1. SUMMARY 4 1.1. EUT configuration 4 1.2. NOTE 4 2. TEST ENVIRONMENT 5 2.1. Address of the test laboratory 5 2.2. Environmental conditions 5 2.3. Statement of the measurement uncertainty 5 3. METHOD OF MEASUREMENT 5 3.1. Applicable Standard 5 3.2. Limit 6 3.3. MPE Calculation Method 6 4. CONCLUSION 7 Report No.: TRE1303011002 Page 4 of 7 Issued:2013-09-23 1. SUMMARY 1.1. EUT configuration The following peripheral devices and interface cables were connected during the measurement: ● - supplied by the manufacturer ○ - supplied by the lab ○ Power Cable Length (m) : / Shield : / Detachable : / ○ Multimeter Manufacturer : / Model No. : / 1.2. NOTE 1. The EUT is an 802.11b/g/n Blood Gas and Chemistry Analyzer ,The functions of the EUT listed as below: Test Standards Reference Report WLAN 802.11b/g/n FCC Part 15 Subpart C (Section15.247) TRE1303011001 MPE REPORT FCC Per 47 CFR 2.1093(d) TRE1303011002 2. The frequency bands used in this EUT are listed as follows: Frequency Band(MHz) 2400-2483.5 5150-5350 5470-5725 5725-5850 802.11b √ － － － 802.11g √ － － － 802.11n(20MHz) √ － － － 3. The EUT provides one transmitter and one receiver. Modulation Mode TX Function 802.11b 1TX 802.11g 1TX 802.11n (20MHz) 1TX . Report No.: TRE1303011002 Page 5 of 7 Issued:2013-09-23 2. TEST ENVIRONMENT 2.1. Address of the test laboratory Shenzhen Huatongwei International Inspection Co., Ltd Keji Nan No.12 Road, Hi-tech Park, Shenzhen, China Phone: 86-755-26715686 Fax: 86-755-26748089 The sites are constructed in conformance with the requirements of ANSI C63.7, ANSI C63.4 (2009) and CISPR Publication 22. 2.2. Environmental conditions During the measurement the environmental conditions were within the listed ranges: Temperature: 15-35 ° C Humidity: 30-60 % Atmospheric pressure: 950-1050mbar 2.3. Statement of the measurement uncertainty The data and results referenced in this document are true and accurate. The reader is cautioned that there may be errors within the calibration limits of the equipment and facilities. The measurement uncertainty was calculated for all measurements listed in this test report acc. to TR-100028-01” Electromagnetic compatibility and Radio spectrum Matters (ERM);Uncertainties in the measurement of mobile radio equipment characteristics; Part 1” and TR-100028-02 “Electromagnetic compatibility and Radio spectrum Matters (ERM);Uncertainties in the measurement of mobile radio equipment characteristics; Part 2 “ and is documented in the Shenzhen Huatongwei International Inspection Co., Ltd quality system acc. to DIN EN ISO/IEC 17025. Furthermore, component and process variability of devices similar to that tested may result in additional deviation. The manufacturer has the sole responsibility of continued compliance of the device. Hereafter the best measurement capability for Shenzhen Huatongwei laboratory is…

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Radiated Emission (Blow 1GHz) Radiated Emission (30MHz-1GHz) Radiated Emission (Above 1GHz) Conducted Emission (AC Mains)